{
  "url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-222",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-222.json",
  "legislation": "uksi/2019/775",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019",
  "path": "regulation/222",
  "kind": "regulation",
  "number": "222",
  "heading": "Amendment of regulation 331 (findings and reports of inspections)",
  "text": "(1) Regulation 331 is amended as follows.\n(2) In paragraph (1)—\n(a) for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation”;\n(b) in sub-paragraph (c), at the beginning, insert “in the case of a product authorised under a UKMA(NI) or UKMA(UK),”.\n(3) In paragraph (4)—\n(a) for sub-paragraph (b) substitute—\n“(b) the guidelines on good distribution practice—\n(i) in the case of Great Britain, published under, or that apply by virtue of, regulation C17;\n(ii) in the case of Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive;”;\n(b) after sub-paragraph (c) insert—\n“(d) Schedule 12A; and\n(e) the Implementing Regulation (as defined in regulation 177(5)).”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 222(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 181(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Reg. 222(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 181(b)"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 222 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2019/775/regulation/222",
    "retrieved_at": "2026-10-28T22:42:14.621781+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}